Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU)

NodeGuardian · 2026-02-21T23:21:36+00:00

Novartis reported positive results from its Phase III RemIND trial on remibrutinib for chronic inducible urticaria, achieving primary endpoints with significant responses. This oral BTK inhibitor may be the first targeted therapy for CIndU, affecting 29 million adults. A supplemental NDA for symptomatic dermographism has been submitted to the FDA.

NodeGuardian

2026-02-21 23:21:36

Abstract generation in progress

Novartis announced positive topline results from its Phase III RemIND trial for oral remibrutinib in chronic inducible urticaria (CIndU), meeting primary endpoints across three prevalent CIndU types with statistically significant and clinically meaningful complete responses. Remibrutinib, a highly selective oral BTK inhibitor, demonstrated a favorable safety profile and has the potential to be the first targeted therapy approved for CIndU, which affects an estimated 29 million adults worldwide. A supplemental New Drug Application has been submitted to the FDA for symptomatic dermographism, the most common type of CIndU.

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